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Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein in Hypercholesterolemia (ProFi)

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Psyllium husks

Isolated soy protein

Isolated whey protein

Microcrystalline cellulose

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

BMI 18,5 - 35 kg/m2
LDL cholesterol > 3,5 mmol/l

Exclusion Criteria:

Triglycerides > 5,0 mmol/l
Use of phytosterols, food supplements containing soy protein or water soluble fiber supplements
Cardiovascular disease
Diabetes mellitus
Gastrointestinal disease
Liver- og kidney disease
Electrolyte imbalance
Orlistat treatment
Alcohol abuse
Hypersensitivity to the interventional substances
Pregnancy and nursing

Sites / Locations

The Lipid Clinic, Aalborg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Combinatorial treatment

Single treatment: Psyllium husks

Single treatment: Isolated soy protein

Control

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in LDL cholesterol at 6 weeks

3rd and 4th visits equal the ends of the 1st and 2nd intervention period at +6 weeks and +16 weeks from baseline respectively (4 week wash-out period in between the intervention periods). 2nd visit includes randomization and baseline measurement, while 1st visit @ -4 weeks compared to baseline includes screening and inclusion

Secondary Outcome Measures

Change from baseline in total cholesterol at 6 weeks

Change from baseline in HDL cholesterol at 6 weeks

Change from baseline in triglycerides at 6 weeks

Change from baseline in fasting plasma glucose at 6 weeks

Change from baseline in body weight at 6 weeks

Change from baseline in apolipoprotein B at 6 weeks

Change from baseline in small, dense LDL cholesterol at 6 weeks

Change from baseline in high sensitive CRP at 6 weeks

Full Information

NCT ID

NCT01251991

First Posted

December 1, 2010

Last Updated

January 28, 2014

Sponsor

Aalborg University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01251991

Brief Title

Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein in Hypercholesterolemia

Acronym

ProFi

Official Title

Additive Cholesterol Lowering Effect by Concomitant Treatment With Psyllium Husks and Isolated Soy Protein in Addition to Heart-healthy Diet in Hypercholesterolemia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aalborg University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Despite improved treatment, cardiovascular disease remains one of the most common diseases and causes of death in the Western world. Hypercholesterolemia is a well known risk factor for developing cardiovascular disease. Prevention and treatment are based in part on lowering LDL cholesterol. Dietary and lifestyle changes always play an important part of the treatment and preventive effort, and conversion to a heart-healthy diet reduces LDL cholesterol by a mean 10%. Further lowering of LDL cholesterol by means of food supplements have been demonstrated in numerous studies. Cholesterol lowering food supplements include isolated soy protein and water soluble dietary fibre such as psyllium husks. Postulated mechanisms of action responsible for the cholesterol lowering in these two food supplements are different, so there is a reason to expect an additive cholesterol lowering effect during concomitant treatment with both substances. The investigators want to investigate whether concomitant treatment with psyllium husks and isolated soy protein in addition to a heart-healthy diet results in a significantly greater reduction of LDL cholesterol in hypercholesterolemia, than single treatment with each of the substances.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combinatorial treatment

Arm Type

Experimental

Arm Title

Single treatment: Psyllium husks

Arm Type

Active Comparator

Arm Title

Single treatment: Isolated soy protein

Arm Type

Active Comparator

Arm Title

Control

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Psyllium husks

Intervention Description

Oral suspension, oral use, two daily dosages consisting of 5 grams each

Intervention Type

Dietary Supplement

Intervention Name(s)

Isolated soy protein

Intervention Description

Oral suspension, oral use, 30 grams once per day

Intervention Type

Dietary Supplement

Intervention Name(s)

Isolated whey protein

Intervention Description

Oral suspension, oral use, 30 grams once per day

Intervention Type

Other

Intervention Name(s)

Microcrystalline cellulose

Intervention Description

Oral suspension, oral use, two daily dosages consisting of 5 grams each

Primary Outcome Measure Information:

Title

Change from baseline in LDL cholesterol at 6 weeks

Description

Time Frame